MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number DSF2233

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/15/2021

Event Type  Injury  

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® conformable thoracic endoprosthesis.On an unknown date in (b)(6) 2020, a dissection in the greater curvature of the arch aorta was observed.The entry was more proximally than the conformable gore® tag® thoracic endoprosthesis.The physician decided to monitor the dissection.On an unknown date, thoracic aorta aneurysm enlargement was observed just above the celiac artery which was located more distally than the conformable gore® tag® thoracic endoprosthesis and observed from when the initial procedure was performed.The physician plan to treat this aneurysm on (b)(6) 2020.This aneurysm was not treated during the initial treatment in 2019.On (b)(6) 2021, the patient underwent reintervention for the aneurysm which was located just proximal to the celiac artery.A conformable gore® tag® thoracic stent graft with active control system was implanted to extend the initial conformable gore® tag® thoracic endoprosthesis distally using a gore® dryseal flex introducer sheath.On an unknown date in (b)(6) 2021, a pseudoaneurysm at the right external iliac artery was discovered.The pseudoaneurysm was caused by access vessel trauma by the gore® dryseal flex introducer sheath during reintervention procedure on (b)(6) 2021.On (b)(6) 2021, a gore® viabahn® endoprosthesis was implanted to treat the pseudoaneurysm.The patient tolerated the procedure.The physician stated that the pseudoaneurysm was not able to be confirmed by the access angiography on (b)(6) 2021.

Manufacturer Narrative

H6: investigation findings, conclusion code.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11343592
• MDR Text Key: 232523838
• Report Number: 3007284313-2021-01258
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR